User Facility Reporting Bulletin, Issue No. 42, Spring/Summer 2003

Center for Devices and Radiological Health, U.S. Food and Drug Administration

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A quarterly bulletin to assist hospitals, nursing homes, and other device user facilities
Issue No. 42 Spring/Summer 2003

In This Issue:

A Fond Farewell to Our Readers Last Issue of the User Facility Reporting Bulletin

Keep Connected with Contacts Listing

FDA/CDRH Websites That Might Be Helpful

Subject Matter Index to UFR Bulletin, Issues 1-42

A FOND FAREWELL TO OUR READERS
LAST ISSUE OF THE USER FACILITY REPORTING BULLETIN!

Eleven years ago, we published the first issue of the User Facility Reporting Bulletin (UFRB) to assist hospitals, nursing homes, and other medical device user facilities in complying with the Medical Device Reporting (MDR) requirement of the Safe Medical Devices Act of 1990 (SMDA). We are sorry to announce that we will discontinue publishing the Bulletin.

Safe Medical Devices Act of 1990

SMDA imposed significant reporting requirements on facilities that use medical devices. Device user facilities such as hospitals, outpatient diagnostic and treatment facilities, and nursing homes were required to report device-related deaths, serious injuries and serious illnesses within ten days of the adverse event to the manufacturer, the Food and Drug Administration (FDA), or both. This was the first time these facilities were required to report to the FDA and manufacturers.

History of the UFRB

SMDA charged the FDA's Center for Devices and Radiological Health (CDRH) to inform user facilities how and when to comply with the various sections of SMDA.

In 1991, CDRH held seven conferences on MDR. CDRH staff presented information vital to participants on the reporting requirements and established contacts with CDRH staff who could help user facilities fulfill their reporting responsibilities.

CDRH asked the conference participants what would help them comply with the new law. Most participants said they would be better prepared to report device problems if they could receive feedback on reports received by CDRH. The participants said it would be helpful to learn what was happening in other facilities in the nation. In response to the suggestions from participants, we began publishing the User Facility Reporting Bulletin in the Spring of 1992.

Our commitment was to report on the safety of medical devices. We further committed the UFRB to provide information about

problems encountered in mandatory reporting,
suggestions for deciding what to report, and
comments received from other readers.

Medical Device Amendments of 1992

In June of 1992, the Medical Device Amendments of 1992 (to the SMDA) became law. The amendments required that user facilities take their reporting one step further from any "information that reasonably suggests that there is a probability that a device has caused or contributed to a reportable event" to any "information that reasonably suggests that a device has or may have caused or contributed to a reportable event."

Reminiscence

Then

To reminisce: our first issue in the Spring of 1992:

• introduced the quarterly UFRB and our logo to our readers,
• described SMDA,
• listed some Frequently Asked Questions (FAQs) received since mandatory reporting began (November 28, 1991),
• described the first 50 reports CDRH received,
• alerted the user facilities that the first semiannual reports were due, and
• published a calendar of meetings where CDRH would be exhibiting SMDA information, speaking, or both.

Now

Our Winter 2002 issue, featured articles on:
• retinal repair risks; needlesticks,
• results of FDA's survey of hospital reprocessors,
• FAQs on reprocessed single-use medical devices user fees,
• questions on registration and listing recently placed on the Reuse website,
• diathermy interactions with implanted leads as well as implanted systems with leads.

Eleven years later, we were still doing our job of providing feedback to our readers.

Discontinuing the UFRB

A few years ago, we began to evaluate the need to continue publishing the UFRB. We were sending 70,000 printed copies of the UFRB through the mail to hospitals, other types of user facilities, and to many individuals. Because of resource limitations, we reduced that number to 10,000 and finally decided to continue to publish online only.

Retrospectively, we affirmed that we had provided the necessary training and education for the user facilities to comply with the SMDA, MDR, and the Medical Device Amendments of 1992. Then, we began to focus more of our attention to providing feedback on adverse events as they were occurring.

In the past few years, we also began publishing information that was not directly related to user facility reporting. This additional information, however, had a direct effect on hospitals, the largest group of medical device user facilities. A prime example of the type of additional information we provided was the extensive attention we gave to the Reuse of Single-Use Devices (SUDs) issue.

After long and careful consideration, we decided that the UFRB had finally served its purpose, and the time had come to discontinue publishing. After 11 years, we end our publication with the Spring/Summer Issue, # 42.

Many of our readers have been with us from the beginning, and some of you have just recently discovered the UFRB. We are sorry that we will no longer be able to serve you.

In closing, we would like to thank you for supporting the Bulletin. We have enjoyed producing each issue, and we will continue to support FDA in its mission to promote and protect the public health.

The following presents ways that you can maintain your awareness of the medical device issues of interest to you.

KEEP CONNECTED WITH CONTACTS LISTING

FDA would like to invite you to be a part of the new and exciting Center for Devices and Radiological Health's (CDRH) Contacts Listing. The Contacts Listing is a tool that CDRH uses to inform people and organizations about medical device news and events that may be of interest to them. For example, if CDRH sponsors a public meeting to discuss policy issues or potential problems areas in your particular area of interest, we would inform you electronically.

Registration to the Contacts Listing is free. When you register, you may choose areas of interests, geographic region, specialties, and affiliations that best describe your interest as well as your organization's interests. You may also unsubscribe or update your information at any time. This is not a typical list service. You will not get messages on a routine basis. You will receive information only when it becomes available and only when it pertains to your areas of interest.

Here are some other examples of what CDRH will notify you about:

teleconferences
recalls and safety issues
new websites
statements of policy or guidance posted on CDRH web sites (e.g., Federal Register notices, press releases, and safety alerts)
collaboration with CDRH on research of a particular issue

You can join by registering at: http://www.fda.gov/cdrh/contactslisting.

FDA/CDRH WEBSITES THAT MIGHT BE HELPFUL

SUBJECT MATTER INDEX TO UFR BULLETIN, ISSUES 1-42

SUBJECT and ISSUE

Computer Database
CDRH's MAUDE System 2
MAUDE Update 10
MAUDE Update 11
MAUDE Update 5
MAUDE Update: Errors in Reporting 3
MAUDE Update: Semi-Annual Reports 4
User Facility Reporting Bulletin and MDR Information Are Now on Internet 14

Electromagnetic Interference (EMI)
FDA and AAMI to Present a Forum on Electromagnetic Compatibility for Medical Devices 10
FDA Concerned About Interference With Medical Devices (EMI) 18
FDA Warns About EMI Risks with Telemetry 31
Implanted Pacemakers: Avoiding Electromagnetic Interference 24
Interference Between Digital TV Transmissions & Telemetry Systems 23
Review of MDR Reports Reinforces Concern About EMI 20

FDA Patient Safety News
FDA Patient Safety News: New Program 38
FDA Patient Safety News: September 2002 40
FDA Patient Safety News: Winter 2002 41

Flowcharts
FDA Device Tracking Regulations: Device and Information Flowchart 6
Flowcharts Promote Internal Reporting Procedures 6
Sample Flowchart: How to Report Incidents Involving Medical Devices, Drugs, Utilities, and Security 6

Forms and Instructions
Abbreviated Instructions for FDA Form 3500A Specific to Medical Device Reporting 15
FDA Form 3419 15
Mandatory MedWatch FDA Form 3500A 15
Where to Get MDR Materials 15

Hospital Beds and Vulnerable Patients
Hospital Side Rails: Preventing Entrapment 21
Hospital Bed Safety Work Group: Highlights of March Meeting 35
Working Group Formed to Address the Problem of Patient Entrapment in Hospital Beds 29
Workshop Held on Hospital Beds and Vulnerable Patients 30

Human Factors
AAMI/FDA Conference Will Address Human Factors in Medical Device Design, Regulations, and Safety 11
Human Factors and Medical Devices 12
Human Factors and Medical Devices: Lack of Device Feedback 14
Importance of Information About Use Error and Human Factors in Adverse Event Reporting 23
We Urge You to Report Medical Devices Design Problems 16

Index
Subject Matter Index to UFR Bulletin Issues 1-16 17
Subject Matter Index to UFR Bulletin Issues 1-26 26
Subject Matter Index to UFR Bulletin Issues 1-36 36
Subject Matter Index to UFR Bulletin Issues 1-42 42

Latex
Adverse Reactions to Natural Rubber Latex 19
Cornstarch As A Glove Donning Powder 21
FDA Answers Latex Glove Questions 21
FDA Clarifies Latex Terminology 19
FDA Issues Final Rule on Natural Rubber Device Labeling 21
FDA Scientists Study Quality Assurance Tests for Latex Gloves 19
Glove Quality and Selection Criteria 19
How FDA Regulates Gloves 19
Latex Allergy: Recent Developments in Glove Use and Safety 39
Natural Rubber Latex Allergy: A MedWatch Success Story 19
Natural Rubber /Latex Allergy: Recognition, Treatment, Prevention 22
New Labeling for Natural Rubber Latex 25

MDR Studies
Contracts Awarded for User Facility Reporting Study 2
Evaluation of Device User Facility Reporting 2
Medical Device Surveillance Network (MeDSuN) 26
Medical Product Surveillance Network (MeDSuN) Ready to Launch First Segment of the Phase II Pilot 36
MEDSUN - Using Facility Reporting for the New Millennium 30
Update on User Facility Reporting Study 4
Medical Device Problems Adverse Reactions to Natural Rubber Latex 19
Alarming Monitor Error 36
Avoiding Sticks from Sharp Containers 25
Biliblanket Phototherapy Light Safety Tips 25
Cell Phones in Healthcare Facilities: Use with Caution 39
Central Venous Catheters and Cardiac Tamponade 33
Complications Related to the Use of Vascular Hemostasis Devices 28
Complications with the Use of Small-bore Catheters in Continuous Spinal Anesthesia 2
Cornstarch As a Glove Donning Powder 21
Cross Contamination of Hemodialysis Machines: An Unexpected Risk 29
Disposable Devices: Time for a Change 21
Effects of Repeated Ethylene Oxide Sterilization on Synthetic Absorbable Sutures 38
Explosions & Fires in Aluminum Oxygen Regulators 25
FDA Cautions Users of Vacuum Assisted Delivery Devices 24
FDA Public Health Web Notification: Cochlear Implant Recipients May Be at Greater Risk for Meningitis 39
FDA Public Health Web Notification: Diathermy Interactions with Implanted Leads and Implanted Systems with Leads 41
Public Health Notification: Human Tissue Processed By Cryolife, Inc. 40
FDA Concerned About Interference With Medical Devices (EMI) 18
FDA Publishes Results of Infusion Pump Investigation 6
FDA Sends Safety Alerts and Public Health Advisories to Warn of Medical Device Risks 8
FDA Warns About EMI Risks with Telemetry 31
FDA Warns About Radioactivity in Radiation Protection Devices 20
FDA Will Co-sponsor Conference on Unprotected Patient Cable and Electrode Lead Wires 8
Full Field Digital Mammography Approved for Use in MQSA-Certified Facilities 30
Glass Capillary Tubes Pose Risks 25
Healthcare Community Alerted to Device Problems During 1994 10
Heating Devices: How to Avoid Burns 21
Hospital Side Rails: Preventing Entrapment 21
Hospital Bed Safety Work Group: Highlights of March Meeting 35
How to Avoid Injuries from Liquid Chemical Disinfectant 27
Implanted Pacemakers: Avoiding Electromagnetic Interference 24
Incorrect Restraint Use: Deadly Protection 21
Infections from Inadequately Reprocessed Endoscopes: FDA & CDC Issue Public Health Advisory 28
Infusion Pump Mishap: Outside The Channel 21
Interference Between Digital TV Transmissions and Telemetry Systems 23
Labor and Delivery Beds: Keeping Newborns Safe from Falls 27
Medical Device Year 2000 Update 25
Medication Errors Associated with Medical Gas Mix-Ups 35
Monitoring Temporary Pacemaker Connections 40
Olympus America Issues Voluntary Recall of Suspect Video Bronchoscopes 38
Oral Medical Syringe Dispensers and Protective Caps 38
Pacing Your Patients 30
Peritoneal Dialysate Overfill and Human Factor Implications 27
Potential Hypersensitivity Reactions to Chlorhexidine-Impregnated Devices 23
Potential Injury from Circumcision Clamps 32
Problems with Biological Indicators 10
Problems with Circumcision Clamps 28
Protecting Your Patient's Eyes 31
Public Health Advisory on Electric Heating Pads Prompted by MDR Reports 16
Public Health Advisory: Potential for Injury from Medical Gas Misconnections of Cryogenic Vessels 35
Public Health Message: Electrode Lead Wires and Patient Cables 24
Public Health Notification: PVC Devices Containing the Plasticizer DEHP 39
Retinal Repair Risks 40
Reporting Needlesticks 40
Risk with Collagen Hemostasis Devices 26
Safeguarding Cardiac Guide Wires: Follow These Tips to Avoid Breakage 24
Safeguarding Contrast Media Injections 33
Safe Infusions 31
Safety Alert Issued for Hospital Bed Side Rails 13
Sending the Wrong Signals 33
Serious Complications Associated with Pulmonary Artery Catheters 30
Serious Injuries from Microwave Thermotherapy Used for Benign Prostatic Hyperplasia 32
Some Antimicrobial Susceptibility Tests Fail to Detect Resistance 9
Steam Resterilization Roughens Surface of Zirconia Ceramic Femoral Heads 20
Using Denture Cleansers Safely 37
Working Group Formed to Address the Problem of Patient Entrapment in Hospital Beds 29
Workshop Held on Hospital Beds and Vulnerable Patients 30

Medical Device Reporting (MDR)
A Review of Mandatory MedWatch Form 3500A and Semiannual Report Form 3419 16
Applying the Safe Medical Devices Act to Nursing Homes 17
Comments Received on Proposed Medical Device Reporting Regulation 2
FDA Begins Inspection of User Facilities 13
FDA Begins Train the Trainer Courses 17
FDA Extends Effective Date for MDR to 7/31/96 15
FDA Holds Train the Trainer Courses 18
FDA Regions Offer MDR Training 18
FDA Sends Public Health Notice About Important Y2K Planning Information 27
FDA Will Present Live Satellite Teleconference 14
Final Civil Penalties Rule Published 13
Handling Adverse Events Reports 33
How to Handle Failed Devices 27
Live Satellite Teleconference on MDR Final Rule 15
MDR Final Regulation to Be Published Soon 10
MDR Program Starter Kit (Table) 14
MDR Teleconference Reaches Large Audience 16
MDR: A Public Health Partnership 14
Medical Device Amendments of 1992 2
Medical Device Tracking: A Case Study 31
Preserving the Evidence! The First Step in An Accident Investigation 23
President's Council on Year 2000 Conversion 27
Public Availability of User Reports 4
Reporting Problems with Medical Devices: Overview 35
Reporting Y2K Adverse Events 28
Review of MDR Reports Reinforces Concern About EMI 20
Those Code 18
Training Medical Personnel to Comply with SMDA 3
User Facility ID Number 4
What to Expect During an FDA User Facility Inspection 24
When to File an MDR Report 12

MedWatch
FDA Announces New MedWatch Program 5
MedWatch Software Available On Internet 18
MedWatch 6
Natural Rubber Latex Allergy: A MedWatch Success Story 19
Obtaining MedWatch Forms and Instructions 5

Miscellaneous
A Note from James L. Morrison, Acting Director 8
Applying the Safe Medical Devices Act to Nursing Homes 17
HCFA to Hold Conferences on Year 2000 (Y2K) Readiness Strategies 26
How to Request MDR Records Under the Freedom of Information Act 11
Lyme Disease: Difficult to Diagnose 26
MDR from an Insurance Company Perspective 11
New Mammogram Requirements Effective April 28 26
A Fond Farewell to Our Readers 42
FDA/CDRH Websites That Might Be Helpful 42

Public Health Advisories, Notifications and Safety Alerts
FDA Public Health Web Notification: Cochlear Implant Recipients May Be at Greater Risk for Meningitis 39
FDA Public Health Web Notification: Diathermy Interactions with Implanted Leads and Implanted Systems with Leads 41
Public Health Notification: Human Tissue Processed By Cryolife, Inc. 40
FDA Safety Alert: Recall of Ob/Gyn and Surgical Products Manufactured by A & A Medical/Rocket USA/LifeQuest 38
FDA Sends Safety Alerts and Public Health Advisories to Warn of Medical Device Risks 8
Infections from Inadequately Reprocessed Endoscopes: FDA & CDC Issue Public Health Advisory 28
Public Health Advisory on Electric Heating Pads Prompted by MDR Reports 16
Public Health Advisory: Potential for Injury from Medical Gas Misconnections of Cryogenic Vessels 35
Public Health Message: Electrode Lead Wires and Patient Cables 24
Public Health Notification: PVC Devices Containing the Plasticizer DEHP 39
Safety Alert Issued for Hospital Bed Side Rails 13

Questions
"FAQs" Pertaining to Reprocessed Single-Use Devices Medical Devices User Fee And Modernization Act of 2002 41
Frequently Asked MDR Questions 16
Frequently Asked Questions 1
Frequently Asked Questions 3
How to Avoid Problems with MDR Reports 11
Questions and Answers 5
Questions and Answers 9
Quiz: Are These Medical Incident Reports Required? 2
Two Questions on Registration and Listing Added to Reuse Website 41

Reader Survey
Analysis of Bulletin Questionnaires 10
Preliminary Results of the Reader Survey 9
Questionnaire 8

Recalls
Olympus America Issues Voluntary Recall of Suspect Video Bronchoscopes 38
FDA Safety Alert: Recall of Ob/Gyn and Surgical Products Manufactured by A & A Medical/Rocket USA/LifeQuest 38

Report to Congress
Highlights of the Report to Congress on User Facility Reporting 7

Reporting Requirements
August 14: Important Enforcement Date for Reprocessing of Single-Use Devices 39
First Semiannual Report Due by July 31 1
Food and Drug Administration Modernization Act of 1977 22

Reuse/Single-Use/Disposable
AAMI/FDA to Hold Conference on Reuse of Single-Use Devices 25
AAMI Seminar for Hospitals That Reprocess Single-Use Devices 37
AAMI Virtual Seminar For Hospitals FDA Regulations for Reprocessing Single-Use Devices 37
August 14: Important Enforcement Date for Reprocessing of Single-Use Devices 39
August 14, 2001: Important Enforcement Date for Hospital Reprocessors of Single-Use Devices 34
Applying the Quality System Regulation to Hospitals that Reprocess SUDs 34
Changes in Enforcement of FDA's Requirements on Reprocessing of Single-Use Devices: Letter from Dr. Feigal (September 25, 2001) 36
Change In Enforcement Deadline for Reprocessed Class II Single-Use Devices 37
Disposable Devices: Time for a Change 21
Establishment Registration & Medical Device Listing 34
Extensions Granted to Enforcement Priorities of Reprocessed Single-Use Devices 35
"FAQs" Pertaining to Reprocessed Single-Use Devices Medical Devices User Fee And Modernization Act of 2002 41
FDA Alerts Users of Reusable Medical Devices 19
FDA Is Seeking Comments and Suggestions on Labeling of Reprocessed Single-Use Devices 37
FDA Releases Final Guidance on the Reprocessing and Reuse of Single-Use Devices 31
FDA Sends Another Letter to Hospitals About Reuse of Single-Use Devices 36
Hazards in Patient-Controlled Analgesia 40
Labeling and Tracking Requirements 34
Medical Device Reporting 34
PMA Submissions Now Due for Reprocessed Class III Single-Use Devices 33
Premarket Approval 34
Premarket Notification 34
Reports of Corrections and Removals 34
Reprocessing of Single-Use Devices: Letter from Dr. Feigal (September 28, 2000) 32
Results of FDA Survey of Hospital Reprocessors of Single-Use Devices 41
Reuse CD ROM Available 39
Reuse Events 30-36
Reuse of Single-Use Devices 29
Reuse of Single-Use Devices Workshops 34
Reuse Teleconference, December 13, 2000 32
Selecting a Third-Party Reprocessor for Single-Use Devices 40
Two Questions on Registration and Listing Added to Reuse Website 41
Using Standards in Premarket Submissions for Reprocessed Single-Use Devices 37

Tracking
Device Tracking 2
Devices to Be Tracked (Table) 3
Devices to Be Tracked as of 8/29/93 (table) 5, 6
Implementing a Medical Device Tracking System at Thomas Jefferson University Hospital 6
Tracking for 26 Devices Is Required 8/29/93 5

User Facility Reporting Bulletin
Cost of Printing Bulletin May Lead To Availability Only On Internet 18
Future of Bulletin Uncertain 24
Last Printing of User Facility Reporting Bulletin 20
List Serve Announcements 34-36
Two Ways to Get the Bulletin In the Future 20

User Reports
A Look at the First 50 User Facility Reports 1
Accessing User Facility Reporting Information on the World Wide Web 20
Confidentiality of User Facility Reports Is Governed by Freedom of Information Act 9
FDA Introduces Study for User Facility Reporting 22
Public Availability of User Reports 4
Summary of User Facility Reporting: 1992-1996 18
The First Year of User Facility Reporting: Part I. A User Facility Perspective 4
Part II. The FDA Perspective 4
What Does FDA Do With Adverse Event Reports? 2
Highlights of the User Facility Medical Device Reporting (MDR) Requirements (Table) 2
It's the Law: User Facility Reporting Under SMDA 1
Safe Medical Devices Act of 1990 1
Semiannual Reports Were Due by July 31 5

User Facility Reporting Bulletin

FDA produces the User Facility Reporting Bulletin quarterly to assist hospitals, nursing homes, and other medical device user facilities in complying with their statutory reporting requirements under the Safe Medical Devices Act of 1990, the Medical Device Amendments of 1992, and the Food and Drug Administration Modernization Act of 1997. The Bulletin's contents may be freely reproduced. Comments should be sent to the Editor.

Editor: Mary Ann Wollerton
Assistant Editor: Edie Seligson
Editor Emeritus: Nancy Lowe

Department of Health and Human Services
Public Health Service Food and Drug Administration
Center for Devices and Radiological Health, HFZ-230
Rockville, MD 20857
FAX: 301-594-0067

Updated July 14, 2003

horizonal rule

Center for Devices and Radiological Health / CDRH

A FOND FAREWELL TO OUR READERS LAST ISSUE OF THE USER FACILITY REPORTING BULLETIN!

KEEP CONNECTED WITH CONTACTS LISTING

FDA/CDRH WEBSITES THAT MIGHT BE HELPFUL

SUBJECT MATTER INDEX TO UFR BULLETIN, ISSUES 1-42

A FOND FAREWELL TO OUR READERS
LAST ISSUE OF THE USER FACILITY REPORTING BULLETIN!